QUANTIA LA(A)

K050487 · Biokit, S.A. · DFC · Apr 26, 2005 · Immunology

Device Facts

• Record ID: K050487
• Device Name: QUANTIA LA(A)
• Applicant: Biokit, S.A.
• Product Code: DFC · Immunology
• Decision Date: Apr 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5600
• Device Class: Class 2

Intended Use

The Quantia Lp(a) is intended as a latex particle enhanced immunturbidimetric assay for the in vitro quantitative determination of lipoprotein (a) [Lp(a)] concentration in human serum or plasma (EDTA, heparin, citrate) on Clinical Chemistry Systems. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation. Quantia Lp(a) Control is intended for use in monitoring the quality control of results obtained with the Quantia Lp(a) reagents by turbidimetry. Quantia Lp(a) standard is intended for use in establishing the calibration curve for the Quantia Lp(a) reagents by turbidimetry.

Device Story

Quantia Lp(a) is a latex particle-enhanced immunoturbidimetric assay; used for in vitro quantitative determination of lipoprotein(a) concentration in human serum or plasma (EDTA, heparin, citrate). Operates on clinical chemistry systems; utilizes turbidimetry to measure antigen-antibody reaction. Includes dedicated control and standard reagents for quality monitoring and calibration curve establishment. Used by laboratory professionals in clinical settings; results assist clinicians in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease risk. Provides quantitative concentration values; aids clinical decision-making when combined with patient clinical evaluation.

Clinical Evidence

Method comparison study evaluated 104 samples with Lp(a) levels ranging from 2.4 to 188 mg/dL on an Abbott AEROSET instrument. Results showed a slope of 1.121 and a correlation coefficient (r) of 0.9754 compared to the predicate device. Precision studies (within-run) using three control levels demonstrated CVs of 2.3% (mean 16.1 mg/dL), 0.9% (mean 57.9 mg/dL), and 1.5% (mean 38.1 mg/dL).

Technological Characteristics

Polystyrene latex particles coated with rabbit IgG anti-human Lp(a). Principle: Particle-enhanced immunoturbidimetry. Energy source: Clinical chemistry analyzer light source (photometric measurement). Connectivity: Standalone reagent kit for use on clinical chemistry systems. Sterilization: Not applicable. Software: None (reagent-based assay).

Indications for Use

Indicated for the quantitative determination of lipoprotein(a) in human serum or plasma to assist in the evaluation of lipid metabolism disorders and assessment of atherosclerotic cardiovascular disease in specific populations.

Regulatory Classification

Identification

A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.

Predicate Devices

• N-latex Lp(a) (K013128)

Submission Summary (Full Text)

{0}

1

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k050487

B. Purpose for Submission:
Clearance of a new device

C. Measurand:
Low-density lipoprotein

D. Type of Test:
Particle Enhanced Immunoturbidimetry

E. Applicant:
Bikit SA

F. Proprietary and Established Names:
Quantia Lp(a)
Quantia Lp(a) Control
Quantia Lp(a) standard

G. Regulatory Information:

1. Regulation section:
21 CFR §866.5600, Low-density lipoprotein Immunological Test System
21 CFR §866 862.1150, Calibrator
21 CFR §862.1660, Quality Control Material (Assayed and Unassayed)

2. Classification:
Class II; Class I (reserved)

3. Product code:
DFC, Lipoprotein, Low-density
JIS, Calibrator
JJX, single (specified) Analyte Controls (Assayed and Unassayed)

4. Panel:
Immunology (82)
Clinical Chemistry (75)

H. Intended Use:

1. Intended use(s):
The Quantia Lp(a) is intended as a latex particle enhanced immunturbidimetric

{1}

assay for the in vitro quantitative determination of lipoprotein (a) [Lp(a)] concentration in human serum or plasma (EDTA, heparin, citrate) on Clinical Chemistry Systems. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation.

Quantia Lp(a) Control is intended for use in monitoring the quality control of results obtained with the Quantia Lp(a) reagents by turbidimetry.

Quantia Lp(a) standard is intended for use in establishing the calibration curve for the Quantia Lp(a) reagents by turbidimetry.

2. Indication(s) for use:
See intended use above

3. Special conditions for use statement(s):
For professional use only

4. Special instrument requirements:
Clinical chemistry analyzers (performance characteristics determined using the AEROSET System)

I. Device Description:
The Quantia Lp(a) Latex Reagent is a suspension of polystyrene latex particles of uniform size coated with rabbit IgG anti-human Lp(a).

The Quantia Lp(a) Control (level I and II) and standard are prepared from human sera containing Lp(a) and sodium azide.

J. Substantial Equivalence Information:
1. Predicate device name(s):
Dade Behring N-Latex Lp(a)

2. Predicate 510(k) number(s):
K013128

3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Quantitative in vitro diagnostic determination of Lp(a) | Quantitative in vitro diagnostic determination of Lp(a) |
| Analyte | Low-density lipoprotein | Low-density lipoprotein |

{2}

| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Matrix | Serum and plasma (EDTA, heparin and citrate) | Serum and heparinized plasma |

# K. Standard/Guidance Document Referenced (if applicable):

CLSI Document EP5-A, EP6-A, EP7-A, and EP9-A2

# L. Test Principle:

The Quantia Lp(a) Latex Reagent is a suspension of polystyrene latex particles of uniform size coated with rabbit IgG anti-human Lp(a). When a sample containing Lp(a) is mixed with the Latex Reagent and the reaction buffer included in the kit, a clear agglutination occurs. The degree of agglutination is directly proportional to the concentration of Lp(a) in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates.

# M. Performance Characteristics (if/when applicable):

# 1. Analytical performance:

# a. Precision/Reproducibility:

A precision study was performed on a AEROSET System using the Quantia Lp(a) Control I and II (low and high) run in duplicate twice a day over twenty days $(n = 80)$ . The within run, between run and total CV were calculated according to CLIS EP5-A and summarized in following table.

| Material | n | Mean (mg/dL) | Within Run CV (%) | Between Run CV (%) | Total CV(%) |
| --- | --- | --- | --- | --- | --- |
| Low | 80 | 16.1 | 2.3 | 2.0 | 3.4 |
| Medium | 80 | 38.1 | 1.5 | 1.1 | 2.6 |
| High | 80 | 57.9 | 0.9 | 0.8 | 1.6 |

# b. Linearity/assay reportable range:

Linearity was assessed according to CLSI EP6-A guideline.

1.28 to $90\mathrm{mg / dL}$ (2.0 to 204 nmol/L) without the automatic rerun capability 1.28 to $360\mathrm{mg / dL}$ (2.0 to 816 nmol/L) with the automatic rerun capability. If after the automatic rerun the concentration of the sample exceeds the linearity range, dilute the sample 1:10 with saline solution, re-assay and multiply the result by the dilution factor of 10.

# c. Traceability, Stability, Expected values (controls, calibrators, or methods):

The Quantia Lp(a) Control (level I and II) are prepared from human sera containing Lp(a), and sodium azide $(< 0.1\%)$ . Refer to control value sheet for assigned values. Verify that the lot number listed on each bottle of the control agrees with the lot number printed on the value sheet. Reconstituted stability testing was performed to support the Quantia Lp(a) Control (low and high) of 15 days at $2 - 8^{\mathrm{0}}\mathrm{C}$ after reconstitution.

{3}

The calibrator is prepared from human sera containing Lp(a) and sodium azide $< 0.1\%$ . Calibration stability testing was performed using the Abbot Clinical Chemistry System AEROSET to support that calibration is stable for at least 30 days. Reconstituted stability testing was performed to support the Quantia Lp(a) Standard of 15 days at $2 - 8^{\circ}\mathrm{C}$ after reconstitution.

# c. Detection limit:

The detection limit was calculated by running thirty replicates of physiologic saline on an AEROSET System. The mean and standard deviation were calculated. The detection limit is defined as the mean reported value for the physiologic saline plus two standard deviations. The detection limit of this assay is $0.38\mathrm{mg / dL}$ .

# d. Analytical specificity:

Interference testing was performed on an AEROSET System by spiking a sample containing Lipoprotein (a). For each interfering substance the sample was split in two aliquots, one being spiked with the concentrated interfering substance and the other with the control buffer (the buffer in which the interfering substance is dissolved). For this study, CLSI EP7-A was followed with the following results that no significant interference by:

Hemoglobin up to $460\mathrm{mg / dL}$

Bilirubin up to $19.6\mathrm{mg / dL}$

Triglycerides up to $1327\mathrm{mg / dL}$

Turbidity of sample up to 2.3 AU/cm at 660 nm

Rheumatoid Factor up to 800 IU/ml

# f. Assay cut-off:

Not applicable

# 2. Comparison studies:

# a. Method comparison with predicate device:

Following CLSI EP9-A2, a comparative performance study was conducted by using 104 patient serum samples analyzed in duplicate with Quantia Lp(a) on an AEROSET System versus predicate, Dade Behring's N Latex Lp(a) on aBNII. The samples concentrations ranged from 2.4 to $188\mathrm{mg / dL}$ of Lp(a). The results from the study are summarized as following:

$\mathrm{Y} = 1.121\mathrm{x} - 0.8;\mathrm{r} = 0.9754;\mathrm{n} = 104$

| Mathematical Method | Linear Regression |
| --- | --- |
| Slope | 1.121 |
| Intercept (mg/dL) | -0.8 |
| Range (mg/dL) | 2.4 – 188 |
| Mean X (mg/dL) | 44.8 |
| Mean Y (mg/dL) | 49.5 |
| R | 0.9754 |
| Syx | 10.76 |
| N | 104 |

{4}

b. Matrix comparison:
The plasma to serum correlation was generated with five sets of 50 paired samples on Hitachi – 917. Sodium EDTA plasma, potassium EDTA plasma, Lithium Heparin plasma, Sodium Heparin plasma and citrate plasma paired to serum samples used. The data from he studies show that results of the the paired serum and different plasma samples were equivalent.

3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
Plasma Lipoprptein (a) concentration have been reported to be independent of body mass, age and sex. Concentrations of Lp(a) up to 30 mg/dL are considered normal.

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.